Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes
University of California, San Francisco
Summary
The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is safe and may help patients recover their movement. The main questions it aims to answer are: * is starting electrical stimulation 3 days post SCI safe? * can starting electrical stimulation 3 days post SCI help patients recover movement? This study will be done in two phases. Both phases will be done during the patient's stay in the hospital/intensive care unit (ICU). In the first phase, participants' will undergo several tests before and after a single treatment. Assessments will be repeated before the patient will go home at around 7 days post injury. * assessment of the ability to move arms/legs and feel touch or pin prick * blood and cerebral spinal fluid draws * assessment of their spinal cord function using electrical stimulation * receive a single 60-minute continuous electrical stimulation treatment * patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings. In the second phase, researchers will compare active electrical stimulation to sham stimulation to see if active stimulation safely leads to improvement in person's movement ability. In this second phase, participants' will undergo tests before and after electrical stimulation treatment which will be delivered 5 days in the row. Assessments will be repeated before the patient will go home at around 7 days post injury. * assessment of the ability to move arms/legs (every day) and feel touch or pin prick (before and after 5 days of treatment) * blood and cerebral spinal fluid draws (before the first treatment session and before going home) * assessment of their spinal cord function using electrical stimulation (before the first treatment session and before going home) * receive daily 60-minute continuous electrical stimulation treatment for 5 days while in ICU * patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings.
Description
Spinal cord injury (SCI) is often devastating, as many SCI patients are permanently disabled resulting in decades of lost productivity and quality adjusted life years. Patients must largely rely on supportive care, as no Federal Drug Administration (FDA)- approved therapy to treat aSCI exists. Even with early aggressive physical therapy, voluntary movement below the level of the lesion is limited or even absent. There is critical unmet need for strategies to preserve neural function and prevent the host of complications in the hyperacute phase after SCI until discharge to acute rehabilitation.…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: A subject will be eligible for enrollment in the study of the following criteria apply: 1. Written informed consent is obtained. 2. Acute traumatic cervicothoracic SCI that meets all of the following criteria: 1. Acute SCI presenting to the hospital within 12 hours of injury 2. Traumatic non-penetrating SCI 3. American Impairment Scale (AIS) Grade A, B, or C 4. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurological level of injury between C4 and T10 3. Aged \>/=18 years 4. Admission to Intensive Care Unite (ICU) w…
Interventions
- Devicetranscutaneous spinal cord stimulation
Transcutaneous spinal stimulation will be delivered using the experimental ARC-EX device (ONWARD Medical), via skin surface electrodes placed over the spine (stimulating electrodes) and bilaterally on the iliac crests (reference electrodes) during the intervention.
- Devicesham transcutaneous spinal cord stimulation
For sham transcutaneous spinal stimulation electrodes will be placed on the skin surface over the spine and bilaterally on the iliac crests and will be attached to the experimental ARCEX device (ONWARD Medical), however no electrical current will be delivered.
Location
- Zuckerberg San Francisco General HospitalSan Francisco, California